Senior Scientist I, Bioassay (Biologics CMC)

Location: Alameda, California, United States; primarily laboratory and office-based

Base salary: $127,500–$180,500 annually, depending on geographic market, qualifications, experience, and internal equity.

Company

hirify.global develops biologic therapeutics and supports analytical and CMC development programs.

What you will do

• Develop, optimize, qualify, transfer, and manage cell-based bioassays and potency assays for biologic therapeutics.
• Perform mammalian cell culture, transient transfection, engineered cell model development, receptor-expression confirmation, and assay-ready cell support.
• Develop and troubleshoot reporter-gene, cytotoxicity, proliferation or inhibition, receptor-blockade, ADCC/CDC, and immune-cell engagement assays.
• Apply flow cytometry, ELISA, plate-based binding assays, SPR, BLI, and other orthogonal methods for assay development, comparability, and structure-function studies.
• Evaluate assay robustness, system suitability, relative potency, parallelism, and critical parameters for phase-appropriate qualification and transfer.
• Prepare assay procedures, development reports, qualification and transfer documents, technical summaries, and regulatory-supporting materials while collaborating with cross-functional and external partners.

Requirements

• Ph.D. in a relevant life sciences discipline with industry experience, or a master’s degree with 5+ years of relevant industry experience, or a bachelor’s degree with 7+ years of relevant industry experience.
• Hands-on experience developing complex cell-based bioassays or functional assays from concept through optimization, qualification, troubleshooting, documentation, and method transfer.
• Advanced knowledge of mammalian cell culture, flow cytometry, receptor-expression analysis, functional assay design, and binding or kinetic methods such as SPR or BLI.
• Ability to translate product mechanism of action and critical quality attributes into assay strategies, biological readouts, controls, and acceptance criteria.
• Working knowledge of biologics CMC, method development, qualification, comparability, method transfer, lifecycle management, and CDMO or CTL interactions.
• Ability to work in laboratory and office settings in Alameda, California, with potential exposure to biological, chemical, hazardous, and extremely cold materials.

Culture & Benefits

• Cross-functional collaboration with Discovery, Translational Sciences, Process Development, Quality, Regulatory, CDMOs, CTLs, and external partners.
• Opportunity to provide technical guidance and training to junior scientists, research associates, consultants, and external partners without direct people-management responsibility.
• Comprehensive employee benefits including 401(k) contributions, medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus eligibility, company stock purchase opportunities, and long-term incentives.
• Fifteen accrued vacation days in the first year, 17 paid holidays including a company-wide winter shutdown, and up to 10 sick days annually.
• Modern office facilities with collaborative workspaces, dual monitors, and ergonomic chairs.